chidamide combined with chope regimen for peripheral t-cell lymphoma patients

Conditions: Experimental Tumor

Summary: chidamide with cyclophosphamide, doxorubicin, vincristine, prednisone and etoposide for peripheral t cell lymphoma patients : a prospective, randomized controlled, open label, phase ii clinical trial

chidamide，a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral t-cell lymphoma in china. the aim of this study was to observe the efficacy and safety of chidamide with cyclophosphamide, doxorubicin, vincristine, prednisone and etoposide for peripheral t cell lymphoma patients.

Eligibility criteria:
inclusion criteria: 1. histopathology / cytology diagnosed as peripheral t cell lymphoma (ptcl) according to who 2016 classification criteria（nk/t cell lymphoma and alk positive anaplastic large cell lymphoma excluded）including:peripheral t-cell lymphoma, nos，angioimmunoblastic t-cell lymphoma，anaplastic large-cell lymphoma, alk negative，enteropathy-associated t-cell lymphoma，hepatosplenic t-cell lymphoma，subcutaneous panniculitis t-cell lymphoma，mycosis fungoides，other t-cell lymphoma that investigators consider to be appropriate to be enrolled; 2. patients have received chope regimen for 2 cycles therapy and achieve pr or sd; 3. patients should have at least one evaluable foci ( lymph nodes with diameter≥1.5cm, or evaluable skin foci); 4. age 18-70 years, male or female; 5. ecog performance status 0-2; 6. absolute neutrophil count ≥1.5×109/l, platelet ≥75×109/l, hb ≥ 90g/l; 7. alt and serum creatinine \<1.5 times of normal maximum; 8. life expectancy no less than 3 months; 9. willing to sign the informed consent form. exclusion criteria: 1. nk/t cell lymphoma or alk positive anaplastic large cell lymphoma; 2. female patients in lactation or pregnancy, childbearing female or male patients unwilling to take contraceptive measures; 3. qtc elongation with clinical significance ( male\> 450ms, female\> 470ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment; 4. patients have undergone organ transplantation; 5. patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment; 6. patients with active hemorrhage; 7. patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction; 8. patients with active infection or continuous fever within 14 days prior to enrollment; 9. had major organ surgery within 6 weeks prior to enrollment; 10. impaired liver function ( total bilirubin \> 1.5 times of normal maximum, alt/ast\> 2.5 times of normal maximum, for patients with infiltrative liver disease alt/ast\> 5 times of normal maximum), impaired renal function (serum creatinine\> 1.5 times of normal maximum); 11. patients with mental disorders or those do not have the ability to consent; 12. patients with drug abuse, long term alcoholism that may impact the results of the trial; 13. patients with invasion of central nervous system ; 14. non-appropriate patients for the trial according to the judgment of the investigators.